Biosimilars

TECHNOLOGICAL ADVANCEMENTS •
REGULATORY AFFAIRS •
COMMERCIAL ASPECTS

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Understanding Biosimilars in a complex regulatory and market environment

This course extrapolates from conventional generics into the specialised area of biosimilars. By combining aspects of technology, regulatory affairs and commercial aspects, this course will provide you with a wide ranging overview of the status of the biosimilar industry.

get the latest insight

Gain a firm understanding of the CMC, Nonclinical & Clinical regulatory requirements and expectations (FDA, EMA and WHO) for biosimilars

expand your knowledge

Appreciate why biosimilars are not treated by the regulatory authorities as bio-generics

get practical

Partake in a comprehensive, scientific biosimilarity exercise to understand what has worked and what has not, when bringing biosimilars to the market

KEEP UP TO SPEED WITH THE BIOSIMILARS MARKET

Biosimilars are very much more complicated than small molecules in terms of manufacturing and testing and this leads to a level of uncertainty that results in additional requirements in terms of regulatory approvals.

Registration processes for these products are completely different in the European Union and the USA, and price rebates are hugely different. Almost daily there are new requirements related to such simple things as how the biosimlar should be named and whether such products are substitutable or not. These changes dramatically affect the strategy companies need to adopt and this course will show how these changes relate to market situations and forward planning.

In just 3 days you will:

Understand the difference between biologic drugs and small molecules

Look at some of the manufacturing constraints in terms of Biosimilar processing

See how these constraint affect regulatory approval processes and market impact

Review the main Bisimilar approvals and the companies working in the Biosimilar space

Get insights into the areas of dispute including nomenclature, substitution, interchangeability and extrapolation

Discover how these areas can have a dramatic effect on market models

Consider the life cycle defence mechanisms of the innovator biologics including scientific approaches and legal and intellectual property issues